Drug Drug Interactions of Aspirin and P2Y12-inhibitors

This study has been completed.
Information provided by (Responsible Party):
Eva-Luise Hobl, Medical University of Vienna
ClinicalTrials.gov Identifier:
First received: June 7, 2011
Last updated: April 7, 2015
Last verified: April 2015
Study Objective: To investigate potential drug-drug interactions (pharmacokinetics and pharmacodynamics) of morphine and antiplatelet drugs (aspirin, clopidogrel, prasugrel, ticagrelor)

Condition Intervention Phase
VA Drug Interactions [VA Drug Interaction]
Myocardial Infarction
Drug: Morphine
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Drug Drug Interactions of Antiplatelet Drugs and Morphine

Resource links provided by NLM:

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Platelet function [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tmax [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Cmax [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 95
Study Start Date: May 2011
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Morphine
Vendal 5 mg i.v. bolus injection
Drug: Morphine
i.v. bolus injection
Other Name: Vendal
Placebo Comparator: Placebo
Sodium chloride 0.9% i.v. bolus injection
Drug: Placebo
i.v. bolus injection
Other Name: Sodium chloride 0,9%

Detailed Description:
Rationale: Opiates reduce the intestinal resorption of orally administered drugs such as paracetamol. Because morphine is often injected to relieve pain in patients with myocardial infarction, it is of particular interest if morphine may decrease the rate of absorption of antiplatelet drugs. Results of this study will provide essential information for the use of morphine and antiplatelet drugs in clinical practice, in particular in myocardial infarction.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy volunteers ≥ 18 years of age
  • No intake of NSARs and P2Y12-inhibitors within 14 days before study entry
  • Written informed consent

Exclusion Criteria:

  • Known coagulation disorders
  • Relevant impairment of hepatic function (elevated transaminases, ≥ 2 fold)
  • Relevant impairment of renal function
  • Infectious diseases (HIV, hepatitis B and C)
  • Gestation and lactation
  • Clinically relevant abnormal laboratory values
  • Use of medication during 2 weeks before the start of the study, which may affect the validity of the study
  • General contraindications for aspirin (resp. clopidogrel, prasugrel, ticagrelor) and morphine
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01369186

Medical University of Vienna, Department of Clinical Pharmacology
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Principal Investigator: Bernd Jilma, Prof. Dr. Medical University of Vienna
  More Information

Responsible Party: Eva-Luise Hobl, Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01369186     History of Changes
Other Study ID Numbers: 2010-023761-22 
Study First Received: June 7, 2011
Last Updated: April 7, 2015
Health Authority: Austria: Ethikkommission
Austria: Federal Office for Safety in Health Care

Additional relevant MeSH terms:
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Analgesics, Opioid
Central Nervous System Depressants
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents

ClinicalTrials.gov processed this record on May 26, 2016